Model Number 1506-00-007 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Pain (1994); Synovitis (2094); No Code Available (3191)
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Event Date 06/12/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Patient was revised to address suspected loosening of the tibial tray at cement to implant interface.Depuy cement was used.Attune tibial tray was found to be grossly loose.Some pitting was observed on the poly insert.Patient was revised to a stemmed attune fixed bearing revision tray with 2 10mm wedges, and a new poly insert.Doi: (b)(6) 2016; dor: (b)(6) 2019; right knee.
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Manufacturer Narrative
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Udi: (b)(4).(b)(4) was added to capture medical device removal.
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Event Description
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Medical records alleges synovitis.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
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Search Alerts/Recalls
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